Simple, at-site detection of diethylene glycol/ethylene glycol contamination of glycerin and glycerin-based raw materials by thin-layer chromatography.
This paper describes a rapid, inexpensive thin-layer chromatographic (TLC) method that separates diethylene glycol (DEG) from glycerin and other glycols. Studies with collaborating laboratories of the World Health Organization have shown that about 6% DEG in glycerin and about 2% DEG in acetaminophen (paracetamol) elixirs may be detected by direct visual inspection of the developed TLC sheets. Staining the sheet permits detection of DEG at less than 0.1%. The method costs less than $1.00 per test and takes 20 min by visual inspection, longer when staining is required. The visual method can be performed without laboratory facilities by personnel having little previous training. Samples testing positive by the visual method can be submitted to a laboratory for confirmation and quantitation of DEG.
Kenyon
A S
AS
U.S. Food and Drug Administration, Division of Testing and Applied Analytical Development, St. Louis, MO 63101, USA.
Shi
X
X
Wang
Y
Y
Ng
W H
WH
Prestridge
R
R
Sharp
K
K
D000082:Acetaminophen; D002855:Chromatography, Thin Layer; D004340:Drug Contamination; D019855:Ethylene Glycol / Q000302:isolation & purification*; D005026:Ethylene Glycols / Q000302:isolation & purification*; D005990:Glycerol / Q000032:analysis*; D007455:Iodine; D011196:Potassium Permanganate; D012996:Solutions / Q000737:chemistry; D013213:Starch; D014944:World Health Organization
D005026:Ethylene Glycols; D012996:Solutions; D011196:Potassium Permanganate; D000082:Acetaminophen; C013484:diethylene glycol; D013213:Starch; D007455:Iodine; D019855:Ethylene Glycol; D005990:Glycerol